MKC-231 is an investigational Alzheimer drug under development by Mitsubishi Pharma Corporation for its potential to support nerve cell communication processes disrupted by Alzheimer's disease. The brain's billions of nerve cells transmit and store information by means of minute electrical signals and specialized messenger chemicals. Cells involved in memory, thought, and judgment that use the messenger chemical acetylcholine are among those affected earliest and most profoundly by Alzheimer's disease. Under normal circumstances, acetylcholine is released by one nerve cell to transmit a message to a neighboring cell. Once the message is received, acetylcholinesterase and other enzymes break down acetylcholine. Choline, one of the resulting raw materials, is then taken up by message-sending cells for reuse.

Scientists have looked at a number of steps in this complex system as potential therapeutic targets. Drugs currently approved for the treatment of Alzheimer symptoms increase the availability of acetylcholine by blocking the activity of acetylcholinesterase.

MKC-231 is based on another approach to supporting the acetylcholine communication system. Evidence suggests that the drug may enhance the function of the high-affinity choline uptake system, one of the cell's mechanisms for getting choline back into the message-sending cell.

Where is MKC-231 in the drug development proscess?
According to Mitsubishi Pharma, data from Phase I trials suggest that MKC-231 is well tolerated. The company also says that in Phase IIA trials, participants who received MKC-231 showed an improvement in cognitive performance compared to individuals who received the placebo (a similar but inactive treatment).

The company is now proceeding with a Phase IIB trial at 45 study centers across the United States. The Phase IIB trial will further evaluate whether MKC-231 has a favorable effect on Alzheimer symptoms. The trial is also designed to assess whether MKC-231 may slow progression of Alzheimer's disease. Previous trials have not provided any credible data that the drug affects progression.

The Phase IIB trial is recruiting men and women who have been diagnosed with Alzheimer's disease or have experienced progressive memory loss. Prospective participants may not currently be taking cholinesterase inhibitors and must have a care partner who is able to participate with them in the study.

Participants will receive study medications and study-related medical care free. In addition, for all individuals evaluated to determine their eligibility for the trial, Mitsubishi Pharma will pay for registration in Safe Return, an Alzheimer's Association program that identifies and recovers individuals with dementia who wander and become lost.